Comparing two treatments for heart attack patients with high thrombus burden

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of intracoronary rhTNK-tPA compared to Tirofiban in patients experiencing ST-segment elevation myocardial infarction (STEMI) with a high thrombus burden. The study will enroll 300 participants who will be randomly assigned to receive either treatment. The primary outcome will be assessed through the corrected TIMI frame count after percutaneous coronary intervention (PCI), while major adverse events will be monitored over a one-year follow-up period. The trial seeks to determine if rhTNK-tPA is as effective as Tirofiban and whether it leads to a higher incidence of bleeding events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-75 years old;
* STEMI within 12 hours of onset;
* TIMI flow grade 0-2 or TIMI thrombus grade ≥4 after thrombus aspiration or balloon dilation
* Radial artery access

Exclusion Criteria:

* A functional coronary collateral supply (Rentrop grade≥2) to the infarctrelated artery
* Known or suspected old myocardial infarction of target vessels
* Rescue PCI
* Cardiogenic shock
* Contraindications to Tirofiban or rhTNK-tPA
* Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate \<30ml/min/1.73m2, or on dialysis)
* Prolonged (\> 10 minutes) cardiopulmonary resuscitation
* Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall)
* Severe chronic obstructive pulmonary disease or respiratory failure
* Severe infection
* Neurological disorders
* Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year
* Pregnant or lactating women

Where it's running

• Fuwai Central China Cardiovascular Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: You Zhang
• Email: 13598019682@126.com
• Phone: +86 37158681037

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Administering adrenaline in STEMI patients during PCI to prevent no reflow

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.